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Supreme court asks NGOs to suggest methods to strengthen clinical trial laws

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The Supreme Court Friday asked the central government to discuss with states all facets of a legal framework to regulate and monitor clinical trials of new drugs by foreign firms across India. A bench of Justice R.M.Lodha and Justice Madan B. Lokur also asked petitioner Swasthya Adhikar Manch, the National Human Rights Commission (NHRC), NGOs and other organisations to submit their suggestions for strengthening the legal regime to regulate clinical trials so as to minimise the harm to the patients upon whom the new drugs were being tested.

The court asked the union health secretary to call a meeting of the chief secretaries/health secretaries of the states and union territories and report to it on the outcome as it directed the next hearing Sep 24. The court’s order came on a public interest litigation by Swasthya Adhikar Manch of Indore and others who sought a halt to ‘unethical’ clinical trials by multinational drug companies of their new products in India and treating of Indian patients as guinea pigs.

Complimenting the NGO and others for focusing on the issue, Justice Lodha said: ‘Your efforts have brought some changes. They (government) have become conscious of difficulties or the problems people are facing.’ Noting that the central govenment has taken some measures to strengthen the mechanism to regulate the clinical trials, the court said: ‘What we are interested in is that what has happened in the past should not get repeated. Arrest the recurrence of death and side effects because of clinical trials.’

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Gas pricing: SC to examine policy, issues notices to Centre, RIL

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New Delhi: Government's controversial decision to raise the price of natural gas reached the Supreme Court which today agreed to examine the matter.

Taking up a PIL filed by CPI MP Gurudas Dasgupta, the court issued notices to the Centre, Reliance Industries Ltd (RIL) and the Petroleum Minister Veerappa Moiley.

The bench headed by Chief Justice P Sathasivam said that the issue raised by the senior MP needs examination and the petition cannot be rejected at the initial stage.

The apex court also sought response from BP Exploration (Alpha) Limited, NIKO Resources Ltd and Ministry for Petroleum & Natural Gas on a PIL filed by CPI MP Gurudas Dasgupta who alleged that no due diligence was done by the government while increasing the price of natural gas.

The court directed the parties to file their response within four weeks and posted the matter for further hearing to September 6.

The MP pleaded for a slew of directions including review of Centre's decision to increase the price of natural gas from USD 4.2 per million British thermal unit (mbtu) to USD 8.4 mbtu from April 1, 2014.

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Supreme Court seeks response from Centre, RIL on gas pricing

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The Supreme Court on Monday issued notices to the Centre and Reliance Industries (RIL) on a public interest litigation (PIL) against the increase in natural gas price, filed by Communist Party of India leader Gurudas Dasgupta and former Union power secretary E A S Sarma.

A bench headed by chief justice P Sathasivam asked the Centre and RIL to respond within four weeks. The next hearing is scheduled on September 6. The central government, petroleum minister M Veerappa Moily, the petroleum ministry, RIL, Niko Resources and BP are among the respondents in the PIL.

“The bench has asked us why Moily is included in the list. To which, we responded there are charges levelled against him which need to be addressed,” Dasgupta’s counsel Colin Gonsalves told Business Standard. The PIL prayed for a stay on the decision to increase the price of domestic natural gas from $4.2 per million British thermal unit (mBtu) to $8.4 a mBtu, applicable from April 2014.

The PIL has also sought the apex court’s intervention in the appointment of a presiding arbitrator for a panel looking into RIL’s right to recover its investment in the KG-D6 block from gas sales, thereby completing the process within six months.

Dasgupta had alleged that the petroleum ministry was sitting on a penalty of $1 billion imposed on RIL in FY12 and also failed to implement relinquishment of 86 per cent of the KG-D6 block area held by RIL.

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Conspiracy behind move to double gas price: PIL

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NEW DELHI: The Supreme Court on Monday issued notices to the Centre, RIL and petroleum minister Veerappa Moily and sought their replies on a PIL which alleges conspiracy in the government's decision to double the price of natural gas from April 2014.

Before seeking replies from the respondents within four weeks, a bench of Chief Justice P Sathasivam and Justices Ranjana P Desai and Ranjan Gogoi sought clarifications from Colin Gonsalves — counsel of petitioners MP Gurudas Dasgupta and ex-power secretary E A S Sarma — and heard RIL counsel Harish Salve.

To Salve's preliminary objections, the bench said, "We cannot brush aside the assertions of an MP at the preliminary stage. You (respondents) file your replies and we will consider it." It fixed hearing on the PIL for September 5.

The petitioners alleged that KG basin gas exploring contractors, RIL and NIKO Resources, entered into a conspiracy with the Centre "to provide exorbitant, unreasonable and excessive profits to the contractors, which will bankrupt the exchequer and severely affect the Indian economy".

They sought quashing of the gas price hike and requested the court to direct the government to ensure that henceforth "the price of domestically produced gas is fixed in rupees and not dollars or any other currency".

"Appoint a court commission comprising independent and fearless officers and experts having expertise in the area of this dispute to inquire into the real cost of gas at the well-head in the KG basin and also into the capacity of the basin itself and related issues raised in the petition," they said.

Dasgupta and Sarma also alleged that certain benefits were being granted to the contractors by government for mala fide and collateral gain which would increase the subsidy burden enormously. They also said the gas price hike would "enormously impact" food and energy security resulting in higher prices of fertilizers, food products and cooking gas affecting the poor.

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Justice Ganguly replies to government posers on Pakistan trip

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KOLKATA: A state government questioning the human rights commission (HRC) chief, who enjoys pay parity with a high court's chief justice, about his leave of absence is unheard of. But that's the uncommon situation Justice Asok Kumar Ganguly found himself in earlier this week when the Mamata Banerjee government shot off a letter seeking clarifications about his recent trip to Pakistan.

The West Bengal HRC chief, who visited Karachi in the first week of June to attend a two-day seminar, sent his reply to home secretary Basudeb Banerjee on Friday. The seminar on June 4 and 5 was jointly organized by the Pakistan Institute of Labour Education and Research and the Hamdard School of Law in collaboration with the Human Rights Law Network. Besides Justice Ganguly, others invited from India as speakers were lawyers Prashant Bhushan, Mukul Sinha and Colin Gonsalves. Justice Ganguly returned to the city on June 6 and joined office from June 7.

Since he took charge in April 2012, the WBHRC has proactively taken up cases ranging from the cartoon controversy to the Kamduni rape-murder in which the government has been embarrassed. WBHRC sources felt the letter could be a sequel to that.

The home secretary's letter, which was sent on Monday, "requested" Justice Ganguly to answer five questions about his trip: whether it was official or private, what its purpose was, who funded it, whether there was any FCRA (Foreign Contribution Regulation Act) violation and if prior permission was taken from the governor.

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HRLN is a division of the Socio-Legal Information Centre (SLIC). SLIC is a non-profit legal aid and educational organization, registered under the Registration of Societies Act, 1860, Indian Public Trust Act, 1950 and the Foreign Contributions (Regulation) Act, 1976.